The Board of Grand Pharmaceutical Group Limited announced that recently the Group's two global innovative compound preparations for the treatment of asthma, namely Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate powder for inhalation II) and Atectura
Breezhaler (indacaterol acetate and mometasone furoate powder for inhalation II, III) with a total of 3 product specifications, were successfully passed the negotiation of China national medical insurance, and were officially included in the category-B medicines management scope in Medicines List for National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2022). The successfully inclusion of Enerzair Breezhaler and Atectura Breezhaler in the national medical insurance catalog will further increase the market coverage of the Group's products in the field of respiratory disease treatment, and provide new treatment method for people receiving long-term asthma treatment. Enerzair Breezhaler is the first triple compound inhalation preparation for asthma indications approved in China for the maintenance treatment of asthma in adults not
adequately controlled with the maintenance combination treatment of long-acting beta2-adrenergic agonist (LABA) and inhaled corticosteroid (ICS). The product has clear efficacy, is convenient to use, and has achieved breakthroughs in three aspects: (1) using an optimized drug combination of ICS, LABA and long-acting muscarinic receptor antagonist (LAMA) (mometasone furoate/indacaterol acetate/glycopyrronium bromide), the three
effective ingredients can provide synergy benefit, and compared with the conventional high dose ICS-LABA and high dose ICS-LABA combined with LAMA opened triple combination, Enerzair Breezhaler can effectively improve the clinical symptoms and lung function of patients with moderate to severe asthma, and significantly reduce the risk of acute attacks; (2) dosing once a day, which significantly facilitates the patient and is expected to improve the compliance; (3) using the advanced Breezhaler inhalation device, which is easy to operate, and provides patients with triple dosing confirmation as audible, tasteable, and visible, enhancing patients' confidence in medication. The phase III clinical study of the product
shows that, compared with high dose Salmeterol-Fluticasone powder for inhalation combined with Tiotropium Bromide Spray opened triple combination, Enerzair Breezhaler can significantly reduce the risk of acute attacks, especially the risk of moderate acute attacks in 24 weeks is reduced by 43%. Atectura Breezhaler is an innovative combination of ICS mometasone furoate and LABA indacaterol acetate for the maintenance treatment of adult and 12 years old above adolescent patients with asthma. Atectura Breezhaler also has the characteristics including "visible and controllable, precise inhalation, once a day" etc. It can significantly improve the lung function of patients and reduce the risk of acute attack, and is a new choice for optimal treatment of asthma patients. The phase III clinical study of the product shows that, compared with high dose Salmeterol-Fluticasone powder for inhalation, Atectura Breezhaler can significantly improve the risk of acute exacerbation in patients, and the risk of severe, moderately severe and all acute attack categories is reduced by approximately 26%, 22% and 19% respectively. The successfully inclusion of Enerzair Breezhaler and Atectura
Breezhaler into the Chinese national medical insurance catalog, on the one hand, reflects that the two products are highly correlated with the innovative product management requirements of the National Healthcare Security Administration in terms of clinical value, patient benefits, and R&D innovation, etc. On the other hand, it is also a manifestation of the Group's social responsibility to improve the accessibility of asthma medicines and enable more asthma patients to use asthma medicines with international quality.